48426 Federal Register / Vol. 70, No.
158 / Wednesday, August 17, 2005 / Notices
agrees that the questions should be
straightforward and specific and
designed them with those objectives in
the forefront. The terms ‘‘healthier’’ and
‘‘more desirable’’ are not included
among the study questions. Use of a fat
content disclosure statement in this
study will be consistent with current
regulations (21 CFR 101.13(h)(1)). The
sugar disclosure used in this proposed
study would accompany a ‘‘good source
of carb’’ claim. In the study, the
disclosure would appear on a product
with ‘‘good source of carb’’ on the front
panel and information in the Nutrition
Facts box that indicates that most of the
carbohydrate in the product is sugars.
The goal of this test is to better
understand how consumers react to a
‘‘good source of carb’’ claim on a
product high in sugar and low in other
carbohydrates. The agency disagrees
with the comment’s suggestion to test a
declaration of calories per serving or
‘‘see nutrition information for calorie
content’’ in lieu of ‘‘not a low calorie
food.’’ The agency considers the
statement ‘‘not a low calorie food’’ to be
an appropriate, explicit statement to
make consumers more aware of calories.
The disclosure ‘‘not a low calorie food’’
is currently seen by consumers in the
marketplace when ‘‘sugar-free’’ claims
No. of Re-
Activity
spondents
Cognitive Interviews
Pretest
Screener
Experiment
Total
1There are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on FDA’s
experience with previous consumer
studies. The cognitive interviews are
designed to ensure that the questions
are worded as clearly as possible to
consumers. The cognitive interviews
would take each respondent 30 minutes
to complete. The pretest of the final
questionnaire is designed to minimize
potential problems in the administration
of the interviews. The pretest is
predicted to take each respondent
approximately 10 minutes to complete.
The screener would be sent via the
Internet to the entire 600,000-household
Internet panel, of which 25 percent
(150,000 households) are predicted to
respond. The brief screener is predicted
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are made on products that are not low
calorie. The experimental study looks at
ranges of carbohydrate content levels for
the products to explore differences in
consumer reaction.
The sixth comment argues that the
study methods are sound and suggests
ways to enhance quality, utility, and
clarity of the information to be
collected. The comment suggests
substituting the soda and frozen dinner
stimuli with pasta, cereal, orange juice
or any fruit. The comment does not offer
a reason for these preferences. The
comment also proposes testing white
bread and whole grain bread as separate
products.
The three products proposed for this
study were selected to understand
whether consumer perception of
carbohydrate content claims varies
when the claim is on a label for a
traditionally high-carbohydrate staple
(bread), a beverage (soda), and a
complete meal (frozen dinner). The
agency does not agree that any of the
substitutions suggested in the comment
would improve the study. The label for
the bread does not indicate whether it
is white, wheat, or another grain.
Consumers will view a label claim on
the front panel for bread labeled simply
‘‘home-style.’’ Some of the respondents
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Annual Frequency per Total Annual Re-
Response sponses
9 1 9 0.5
150 1 150
150,000 1 150,000
10,000 1 10,000
to take each respondent 36 seconds to
complete.
The experiment would be conducted
with 10,000 panel members. The
experiment is predicted to take each
respondent approximately 7 minutes to
complete.
Dated: August 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–16242 Filed 8–16–05; 8:45 am]
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who view the Nutrition Facts Panel for
the bread will see a higher-fiber, lower-
fat bread, while others see a lower-fiber,
higher-fat bread. The analysis will
evaluate the differences in perception of
the claims when the nutrient profile
suggests a more healthful versus a less
healthful product.
The seventh comment and eighth
comments address the quality, utility,
and clarity of the information to be
collected. The comments request that
this data collection test changes to the
carbohydrate section of the Nutrition
Facts Panel. One of these comments
requests that fiber and sugar alcohols be
listed separately from other
carbohydrates. The other of the
comments proposes moving
carbohydrates with reduced caloric
value from the carbohydrate listing on
the Nutrition Facts Panel and adding a
listing called ‘‘low calorie ingredients,’’
which would include the subheadings
listings ‘‘fiber’’ and ‘‘other.’’
Evaluating any proposed changes to
the Nutrition Facts Panel is outside the
scope of this data collection. This data
collection is designed to evaluate
consumer understanding of
carbohydrate claims on the front panel.
FDA estimates the burden of the
collection of information as follows:
Hours per Response Total Hours
5
0.17 26
0.01 1,500
0.12 1,200
2,731
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2005C–0302, 2005C–0303, and
2005C–0304]
CIBA Vision Corp.; Filing of Color
Additive Petitions
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that CIBA Vision Corp. has filed three
petitions proposing that the color
additive regulations be amended to
17AUN1
 Federal Register / Vol. 70, No. 158 / Wednesday, August 17, 2005 / Notices
provide for the safe use of Color Index
(C.I.) Pigment Violet 19, C.I. Pigment
Yellow 154, and C.I. Pigment Red 122
as color additives in contact lenses.
FOR FURTHER INFORMATION CONTACT:
Regarding CAPs 5C0278 and 5C0280:
Celeste Johnston, Center for Food
Safety and Applied Nutrition (HFS–
265), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–
3835, 301–436–1282.
Regarding CAP 5C0279: Harold
Woodall, Center for Food Safety
and Applied Nutrition (HFS–206),
Food and Drug Administration,
5100 Paint Branch Pkwy., College
Park, MD 20740–3835, 301–436–
1259.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(sec. 721(d)(1) (21 U.S.C. 379e(d)(1))),
notice is given that three color additive
petitions (CAP 5C0278, Docket No.
2005C–0302; CAP 5C0279, Docket No.
2005C–0303; CAP 5C0280, Docket No.
2005C–0304) have been filed by CIBA
Vision Corp., 11460 Johns Creek Pkwy.,
Duluth, GA 30097–1556. The petitions
propose to amend the color additive
regulations in 21 CFR part 73 to provide
for the safe use of C.I. Pigment Violet 19
(CAP 5C0278), C.I. Pigment Yellow 154
(CAP 5C0279), and C.I. Pigment Red 122
(CAP 5C0280), as color additives in
contact lenses.
The agency has determined under 21
CFR 25.32(l) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
Dated: July 22, 2005.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. 05–16332 Filed 8–16–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting
Consumer Representative Members on
Public Advisory Committees
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
nominations for voting consumer
representatives to serve on the National
VerDate jul<14>2003 13:34 Aug 16, 2005 Jkt 205001
Mammography Quality Assurance
Advisory Committee (NMQAAC) in the
Center for Devices and Radiological
Health (CDRH). FDA has a special
interest in ensuring that women,
minority groups, and individuals with
disabilities are adequately represented
on advisory committees and, therefore,
encourages nominations of qualified
candidates from these groups.
DATES: Nominations will be accepted
through January 31, 2006.
ADDRESSES: All nominations should be
sent to the contact person listed in the
FOR FURTHER INFORMATION CONTACT
section of this document.
FOR FURTHER INFORMATION CONTACT:
Michael Ortwerth, Advisory Committee
Oversight and Management Staff (HF–
4), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, e-
mail: Michael.Ortwerth@fda.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
consumer representatives to serve on
the NMQAAC.
I. Functions of NMQAAC
The functions of the committee are to
advise FDA on the following topics: (1)
Developing appropriate quality
standards and regulations for
mammography facilities; (2) developing
appropriate standards and regulations
for bodies accrediting mammography
facilities under this program; (3)
developing regulations with respect to
sanctions; (4) developing procedures for
monitoring compliance with standards;
(5) establishing a mechanism to
investigate consumer complaints; (6)
reporting new developments concerning
breast imaging which should be
considered in the oversight of
mammography facilities; (7)
determining whether there exists a
shortage of mammography facilities in
rural and health professional shortage
areas and determining the effects of
personnel on access to the services of
such facilities in such areas; (8)
determining whether there will exist a
sufficient number of medical physicists
after October 1, 1999; and (9)
determining the costs and benefits of
compliance with these requirements.
II. Criteria for Members
Persons nominated for membership
on the committee as a consumer
representative must meet the following
criteria: (1) Must be from among
national breast cancer or consumer
health organization with expertise in
mammography, (2) be able to analyze
technical data, (3) understand research
design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy
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48427
of products under review. The
consumer representative must be able to
represent the consumer perspective on
issues and actions before the advisory
committee; serve as a liaison between
the committee and interested
consumers, associations, coalitions, and
consumer organizations; and facilitate
dialogue with the advisory committees
on scientific issues that affect
consumers.
III. Selection Procedures
Selection of members representing
consumer interests is conducted
through procedures that include use of
organizations representing the public
interest and consumer advocacy groups.
The organizations have the
responsibility of recommending
candidates of the agency’s selection.
IV. Nomination Procedures
All nominations must include a cover
letter, a curriculum vita or resume
(which should include nominee’s office
address, telephone number, and e-mail
address), and a list of consumer or
community-based organizations for
which the candidate can demonstrate
active participation.
Any interested person or organization
may nominate one or more qualified
persons for membership on the
NMQAAC to represent consumer
interests. Self-nominations are also
accepted. Nominations shall include
complete curriculum vitae of each
nominee, current business address and
telephone number, and shall state that
the nominee is aware of the nomination,
is willing to serve as a member, and
appears to have no conflict of interest
that would preclude membership. FDA
will ask the potential candidates to
provide detailed information concerning
such matters as financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflict of interest.
The term of office is up to 4 years,
depending on the appointment date.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: August 10, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05–16330 Filed 8–16–05; 8:45 am]
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